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http://www.newsinferno.com/archives/3670Merck’s Gardasil Push Ignored Important Questions
Date Published: Wednesday, August 20th, 2008
In the past two years, Merck & Co. has been spending big to market its Gardasil vaccine, and the effort has been paying off. Catchy television commercials urging parents to make sure their daughter is “one less” victim of cervical cancer, coupled with aggressive lobbying of women’s group, medical societies and politicians has made Gardasil one of Merck’s fastest growing products. But critics of Merck say that the company’s Gardasil marketing campaign has created a panic about a type of cancer that - in Western countries anyway - is preventable through other means, and ignores serious questions about the vaccine’s safety and effectiveness. ...
Merck has seen a big payoff from these efforts. According to The New York Times, Gardasil has now been made available to the poorest girls in the country, up to age 18, at a potential cost to the United States government of more than $1 billion. Proposals to mandate the vaccine for girls in middle schools have been offered in 24 states, and one will take effect in Virginia this fall.
But critics of Merck say the company has overstated Gardasil’s proven potential. Gardasil was only studied in clinical trials for five years. Some data from those trials indicated immunity may wane after three to five years. That means young girls immunized at 11 could have no protection by the time they enter college. Others say Merck is exploiting fears of a type of cancer that can be easily prevented through regular Pap tests. In fact, cervical cancer has not been a major killer in western countries like the U.S. for decades. And Gardasil vaccination doesn’t even eliminate the need for regular Pap tests because it doesn’t protect against all forms of HPV.
Then there are the reported Gardasil side effects. According to an analysis released June 30 by the Washington, D.C.-based public interest group Judicial Watch, there have been 9,749 adverse reactions following Gardasil and 21 reported deaths since 2006. Those side effects, which were reported to the Vaccine Adverse Event Reporting System (VAERS) included 10 miscarriages, 78 severe outbreaks of genital warts and six cases of Guillain-Barré syndrome, an autoimmune disorder that can result in paralysis. Earlier this week, Australian regulators said they were investigating three cases of pancreatitis that followed Gardasil administration. No one can say for sure if any of these side effects are the result of Gardasil. But many believe the vaccine was not subject to enough pre-market scrutiny. According to The New York Times, the FDA expedited Gardasil’s approval application, and gave it the ok in just six months. It was recommended by the CDC just weeks later.
more ...http://www.iht.com/articles/2008/08/19/america/vaccine.phpIn two years, cervical cancer has gone from obscure killer confined mostly to poor nations to the West's disease of the moment. Tens of millions of girls and young women have been vaccinated against the disease in the United States and in Europe in the two years since two vaccines were given government approval in many countries and, often, recommended for universal use among females from 11 to 26. ... The lightning-fast transition from newly minted vaccine to must-have injection in the United States and Europe represents a triumph of what the manufacturers call education and their critics call marketing. The vaccines are far more expensive than earlier vaccines against other diseases - Gardasil's list price is $360 for the three-dose series, and the total cost is typically $400 to nearly $1,000 when including markup and office visits.
The vaccine makers have also brought attention to cervical cancer by providing money for activities by patients' and women's groups, doctors and medical experts, lobbyists and political organizations interested in the disease, sometimes in ways that skirt disclosure requirements or obscure the companies' involvement. In the United States, hundreds of doctors have been recruited and trained to give talks about Gardasil - $4,500 for a lecture - and some have made hundreds of thousands of dollars. Politicians in Britain have been invited to receptions catered with drug company money. Legislators in dozens of countries willingly rallied behind a vaccine that combined two popular, hot button issues: cancer prevention and women's health. "There was incredible pressure from industry and politics," said Dr. Jon Abramson, a professor of pediatrics at Wake Forest University who was chairman of the committee of the U.S. Centers for Disease Control and Prevention that recommended the vaccine for all girls from age 11 or 12 through 26, though he later opposed state proposals to require it. ...
Some experts are concerned about possible side effects that become apparent only after a vaccine has been more widely tested over longer periods. And why the sudden alarm in developed countries about cervical cancer? some experts ask. A major killer in the developing world, particularly Africa, where the vaccines are too expensive for use, cervical cancer is almost always preventable through regular Pap smears that detect precancerous cells effectively. Indeed, because the vaccines prevent only 70 percent of cervical cancers, Pap smear screening must continue anyway. ...
Harper said that in the data from Merck's clinical trials, which she helped conduct, the vaccine was no longer protective after just three years in some girls. "The immunity of Gardasil will not last - that is dangerous to assume," she said. She believes that at least one booster shot, and probably more, will be needed over the course of a lifetime. Other independent experts have worried that eliminating the two cancer-causing HPV strains covered by Gardasil and Cervarix might actually allow the other cancer-causing strains of HPV to increase in frequency, reducing the vaccine's effect. But Haupt said these were "theoretical possibilities" that should not deter rapid distribution of an important vaccine. "We'll worry about whether boosters are needed down the road," he said.
much more ...http://abcnews.go.com/Health/story?id=5620282&page=1First, Gardasil's long-term effectiveness is unclear. Because cervical cancer takes years to develop, critics say the current information is insufficient to determine whether Gardasil works. "The overall effect of the vaccines on cervical cancer remains unknown," Dr. Carolyn J. Haug, the Journal of Norwegian Medical Association's editor, wrote in the New England Journal editorial. "The real impact of HPV vaccination on cervical cancer will not be observable for decades."
Gardasil is also expensive, costing about $400 to $1,000 for the necessary three doses of the vaccine. Studies have not proven how long the immunity will last and whether or not additional shots will be needed, which would raise the cost even higher. And it's not a slam dunk. The vaccine only protects against some of the viruses that cause cervical cancer, so women still need regular pap screenings. And some doctors said that a traditional pap screen may be more effective.
These remaining questions have prompted some doctors to ask if it's worth it for girls to get vaccinated in the first place. "Most of the information people have right now leads them to believe that if they're vaccinated with Gardasil, they're protected for life, and that's just not true," said Dr. Diane Harper of Dartmouth College.
There is also the issue of side effects. FDA records reveal that, since Gardasil's approval, nearly 9,000 girls had "bad health events" after receiving their shots. These included 78 reported outbreaks of genital warts, 18 deaths and six cases of Guillain Barre Syndrome, which can result in paralysis. It is unknown whether there are unseen side effects, like decreasing the body's ability to fight off other strains of the HPV virus. http://www.wjbf.com/midatlantic/jbf/news_index/health_news.apx.-content-articles-JBF-2008-08-21-0009.htmlGardasil: Cervical Cancer Vaccine's Effectiveness Questioned
Many are rethinking whether the Gardasil vaccine is worth it
New York -- Sonya Sheehan's daughters are the picture of health, and she wants to keep it that way. So Sheehan, a nurse, had her older daughter innoculated with Gardasil, the human pappiloma virus (HPV) vaccine, and in a few years....
Sharyn Alphonsi, reporting: "And are you going to give the shots to your six-year-old?"
Sonya Sheehan: "Yes."
Sharyn Alphonsi: "Why?"
Sonya Sheehan: "Because it will protect her against cervical cancer."
Most medical organizations strongly advocate using the HPV vaccine for girls 11- and 12-years-old. And a massive marketing campaign has caught the attention of parents. But, an editorial, published in the New England Journal of Medicine Thursday outlines some serious concerns about the vaccine. First, cervical cancer takes years to develop, so it could be decades before we know of Gardasil's long-term effectiveness. And it could require additional shots.
Sharyn Alphonsi: "And it's not a slam dunk. The vaccine only protects against some of the viruses that cause cervical cancer, so women still need regular screenings. Which is why some doctors are now asking if it's worth it?"
Dr. Diane Harper, Dartmouth College: "Most of the information people have, right now, leads them to believe that if they're vaccinated with Gardisil, they're protected for life...and that's just not true."
Then, there is the issue of side effects. The FDA records reveal that since Gardasils approval, nearly 9,000 girls suffered from "bad health events" after their shots...including 78 outbreaks of gential warts, 18 deaths, and six cases of Guillaine-Barre Syndrome that can result in paralysis. ...http://www.pharmatimes.com/WorldNews/article.aspx?id=14179Still, Kim and Goldie add that the real impact of HPV vaccination on cervical cancer will not be observable for decades, a point stressed in an accompanying editorial by Charlotte Haug, editor of the Journal of the Norwegian Medical Association, She notes that several strains of HPV can cause cervical cancer, and two vaccines directed against the currently most important oncogenic strains (the HPV-16 and HPV-18 serotypes) represent good news. However, “the bad news is that the overall effect of the vaccines on cervical cancer remains unknown,” she adds.
Dr Haug goes on to note that “despite great expectations and promising results of clinical trials, we still lack sufficient evidence of an effective vaccine against cervical cancer”. She says that the jabs protect against only two strains, yet published reports of trials show an increasing trend of precancerous cervical lesions caused by HPV serotypes other than HPV-16 and HPV-18. Those results were not statistically significant, however, possibly because there were too few clinically relevant endpoints in the observation periods reported. She acknowledges the pressure on policymakers worldwide to introduce the HPV vaccine but asks how they can make “rational choices about the introduction of medical interventions that might do good in the future, but for which evidence is insufficient, especially since we will not know for many years whether the intervention will work or – in the worst case – do harm”?
While describing the model presented by Kim and Goldie as “well done and ambitious”, Dr Haug says that “their base-case assumptions are quite optimistic”. They presume lifelong protection(no need for a booster dose), “that the vaccine has the same effect on preadolescent girls as on older women, that no replacement with other oncogenic strains of HPV takes place, that vaccinated women continue to attend screening programs, and that natural immunity against HPV is unaffected”. She concludes by saying that “whether these assumptions are reasonable is exactly what needs to be tested in trials and follow-up studies” and “with so many essential questions still unanswered, there is good reason to be cautious about introducing large-scale vaccination programmes”. http://www.medscape.com/viewarticle/579364Caution Urged Over Large-Scale HPV Vaccination Programs
Zosia Chustecka
August 20, 2008 — "There is good reason to be cautious about introducing large-scale vaccination programs" with the human papillomavirus (HPV) vaccines, because many essential questions are still unanswered. This is the conclusion of Charlotte Haug, MD, PhD, from the Journal of the Norwegian Medical Association, in Oslo, writing in an editorial in the August 21 issue of the New England Journal of Medicine.
"The real impact of HPV vaccination on cervical cancer will not be observable for decades," Dr. Haug comments, but there has been pressure on policy makers worldwide to introduce the HPV vaccine in national or statewide vaccination programs.
Two HPV vaccines are marketed worldwide — the United States and Australia use Gardasil (Merck & Co), while the United Kingdom recently announced that it has chosen Cervarix (GlaxoSmithKline). A major target of these vaccination programs is girls between 12 and 13 years old, as the vaccine is most effective before the onset of sexual activity.
However, Dr. Haug questions how policy makers can make "rational choices about the introduction of medical interventions that might do good in the future but for which evidence is insufficient, especially since we will not know for many years whether the intervention will work or — in the worst case — do harm?" http://www.onlineopinion.com.au/view.asp?article=7786The Gardasil 'miracle' coming undone?
The Therapeutic Goods Administration (TGA) has announced that it is investigating whether there is a link between Gardasil, the vaccine against the human papilloma virus (HPV) and the development of pancreatitis in three young women as reported in a letter to the Medical Journal of Australia. This investigation is good news - but not one minute too early. While the TGA are doing this work, they should also look in detail at the other adverse effects that have been reported in Australia and around the world. And it’s not just “headaches, redness at the injection site, nausea and vomiting” as the TGA claims. There are many serious reports including seizures, debilitating tiredness, body rashes, serious walking problems, severe menstrual pain and irregularities, chest pain, anaphylactic reactions. And these symptoms can persist for weeks, sometimes months. Then there is Guillain Barré Syndrome (paralysis), Acute Demyelinating Encephalomyelitis (ADEM, a neurological disorder characterised by inflammation of the brain), miscarriages and fetal abnormalities in women who were mistakenly administered the vaccine while pregnant.
Not to mention the 17-20 deaths that have been associated with the vaccine in the USA (reported to the federal Vaccine Adverse Events Reporting System, VAERS) as well as one death in Germany and one in Austria. Like Jessica Ericzon, a 17-year-old student who was a softball player but collapsed and died two days after receiving the second Gardasil shot. Or 14-year-old Jenny and her sad story of rapidly deteriorating motor neurone disease following the Gardasil injection. Her family is desperately seeking “comparables”, other girls with similar conditions, whose treatment might help save their severely ill daughter. ...
The third reason can be found in media reports which too often unquestioningly repeat what is fed to them by vaccine advocates. The fact is that HPV as well as cervical cancer are complicated and messy scientific phenomena with lots of question marks remaining. This complexity is difficult to explain. So the over enthusiastic media message gets simplified to “Gardasil Prevents 70 per cent of Cervical Cancer”. And parents who want to do the responsible thing sign their daughters up for vaccination. But no one knows if Gardasil will ever prevent a single case of cervical cancer. There is certainly no proof to date because cervical cancer can take 20 to 30 years to develop and research into the HPV vaccine has only taken place for the past five years. What manufacturer-sponsored researchers have claimed as success was seeing fewer benign lesions develop in research participants. ...
It’s also unclear if HPV “causes” the cancer or, rather, is “associated” with it (e.g. already existing cancer cells might spread more rapidly if HPV is present). Most importantly, there are an estimated 20-40 HPV strains that infect the female genital tract and of those Gardasil covers only two “high” risk strains (16 and 18) and also 6 and 11 which can lead to genital warts. The great worry is that even if strains 16 and 18 were neutralised by the vaccine, other virus strains might become more active. This is a very important point because it appears that most infections are “mixed”, that is they consist of a number of HPV strains (see “HPV Vaccination - More Answers, More Questions” by George F. Sawaya, M.D., and Karen Smith-McCune, M.D., Ph.D. in the New England Journal of Medicine 356:1991-1993).
more ...http://www.irishtimes.com/newspaper/ireland/2008/0821/1219243766868.htmlImportant questions about cancer vaccine
New research casts some doubts over the vaccine and vindicates a decision by Mary Harney not to approve a catch-up programme
RESEARCH INTO cervical cancer vaccination and an accompanying editorial, published today in the New England Journal of Medicine, highlight the intricate calculations and assumptions made by experts when they attempt to assess the cost-effectiveness of new health interventions. Following on from the decision earlier this month by Minister for Health Mary Harney to green-light a national human papilloma virus (HPV) vaccination programme from September 2009, this latest research allows us to examine this policy decision through a lens of a different shade. ...
But the Harvard researchers raise a number of questions: Will the vaccine ultimately prevent cervical cancer and lower deaths and not just prevent non-invasive forms of the cancer? How long will protection conferred by HPV vaccine last? Will there be a need for a 10-year booster injection? Will vaccination affect attendance at screening programmes when the adolescent girls reach their 20s and 30s?
In addition, the Norwegian editorial writer is concerned that the suppression of HPV-16 and HPV-18 (the desired effect of the vaccine) may allow other strains of the virus to grow instead. Could these other serotypes - there are over 200 HPV types in total - emerge as cancer causing agents in response to the eradication of types 16 and 18? While the Harvard authors found that vaccinating 12-year-old girls was cost effective in an American context, the editorial suggest they may have been over optimistic in their basic assumptions. "Whether these assumptions are reasonable are exactly what needs to be tested, in trials and follow-up studies. If the authors' baseline assumptions are not correct, vaccination becomes less favourable and even less effective than screening alone," the writer notes.http://www.healthnews.com/family-health/womens-health/the-payoff-panic-the-success-gardasil-1623.htmlThe Payoff of Panic: The Success of Gardasil
By: Lara Endreszl
Is Gardasil the food bunker of the new millennium? Way back in 1999, you knew someone who was nervous that their bank account would be destroyed, their perishables perished, and time as they knew it wiped out at midnight on December 31st. When nothing happened you could hear the big sigh of relief, and buyers' remorse, of everyone who stocked up their homes for weeks with dried foods and bottled water. In mid-2006, a drug was approved to vaccinate young girls from the danger of the human-papillomavirus, or HPV—the main cause of cervical cancer in women—and the media went nuts.
Elizabeth Rosenthal of the International Herald Tribune states, "Although cervical cancer kills close to 300,000 women a year globally, pap smears and follow-up treatment limit the death toll in countries with good medical care." In fact, in the United States there are less than 4,000 deaths per year to cervical cancer. Elizabeth goes on to point the finger at the pharmaceutical company Merck who dreamed up this aggressive nature behind the vaccine's push. Dr. Diane Harper, who directs the Gynecologic Cancer Prevention Research Group and is a professor of medicine at Dartmouth Medical School, investigated the clinical trial of Gardisil and thinks Merck crossed a line in its marketing campaign, "Merck lobbied...and went directly to the people—it created a sense of panic that says you have to have this vaccine now."
In developing Gardisil, Merck saw dollar signs in their future and they weren't wrong. Having already raked in between $1.4 - 1.6 billion in sales in 2008, Merck worked its magic publicity on doctors, politicians, nurses, schools, and the media to enforce the issue of cervical cancer as a needed preventative measure using Gardasil as the saving grace behind lurking HPV statistics. Doctors can gain up to $4,500 per lecture on the drug and many have been recommending it to their patients since it was approved by the Food and Drug Administration (FDA) in June 2006. Doctor's offices are able to bump up their profits on Gardasil by charging a per needle fee when one series usually costs $361. (Gardasil is a series of three vaccines given over a six-month time period.) But hurry, Merck warns it's only approved in women ages 11 to 26.
Some say the FDA acted too quickly and gave the green light too fast to the vaccine. Gardasil only covers 70 percent of cervical cancers and women still have to get regular pap tests. Gardasil's effectiveness is under question; when most new drugs take years to be approved, Merck's baby got its stamp at just six months. Gardasil only went through clinical trials for five years and data is now surfacing that the immunity to the types of cervical cancer could start to lessen in as little as three to five years. So girls who get the treatment at eleven might still be at risk during their high school years. Is the value of a dollar more important than the value of a life? If Merck doesn't know the long-term effects yet, we are left to wonder why the FDA was so quick to approve it. Would this then require vaccinated women to get re-vaccinated? I guess I'll find out at thirty, but at least now I don't have a shed full of freeze-dried ice cream.http://www.pharmalot.com/2008/08/gardasil-isnt-worth-the-cost-for-women-over-18/Current data has only looked at Gardasil’s ability to stop HPV for up to five years. It is unknown whether Gardasil can reduce overall rates of cervical cancer and deaths, Charlotte Haug, editor-in-chief of the Journal of the Norwegian Medical Association, wrote in a separate editorial also published in the New England Journal.
“There is good reason to be cautious about introducing large-scale vaccination programs,” Haug tells Bloomberg. “Instead, we should concentrate on finding more solid answers through research rather than base consequential and costly decisions on yet unproven assumptions.”http://www.justicenewsflash.com/2008/08/20/gardasil/The instant fame of Gardasil ignored important risks
August 20, 2008
West Palm Beach, Florida – The approved Gardasil vaccine prevents the spread of human papillomavirus, known as HPV (a sexually transmitted virus that can cause cervical cancer in women.) With strong slogans such as “Be one less victim” and the strong push from doctors and medical companies, Gardasil has become extremely popular in the past few years. The vaccine’s manufacturer, Merck & Co. Inc., says it has distributed more than 26 million Gardasil vaccines worldwide, including nearly 16 million in the United States. Merck estimates that 8 million girls and women have received the vaccine in the United States, yet these amounts are quite shocking since the Food & Drug Administration (FDA) only approved Gardasil in June of 2006. ...
Yet, there are many who oppose this vaccine. Many argue that Gardasil’s marketing campaign created an unnecessary panic about a type of cancer that is preventable through regular gynecologist check-ups and Pap smears. Cervical cancer has not been a major killer in western countries for decades. Critics state that the manufacturers of Gardasil had pushed it too quickly, therefore overlooking serious questions about the vaccine’s safety and effectiveness. Gardasil was only studied in clinical trials for five years, with results that showed a decreased immunity after three to five years. (Meaning that a girl at age 11, who gets the shots, could possibly not even be protected by her first year of college. Young girls, who have had the vaccine, have complained of serious side effects. Judicial Watch (a Washington, D.C.-based public interest group) found that there has been 9,749 adverse reactions following Gardasil and 21 reported deaths since 2006. ‘Those side effects, which were reported to the Vaccine Adverse Event Reporting System (VAERS) included 10 miscarriages, 78 severe outbreaks of genital warts and six cases of Guillain-Barré syndrome, an autoimmune disorder that can result in paralysis.’
These grave effects are the result of what happens when a product is rushed on the market. It is sad that so many young girls are experiencing these outcomes and there may be more added to them when around 12 state legislatures are considering mandating this shot for preteen girls before they begin school.http://www.usatoday.com/news/health/2008-08-20-hpv-QnA_N.htm But because cancers typically take decades to develop, it may be many years before doctors know for sure if it prevents cancers, says Charlotte Haug of the Journal of the Norwegian Medical Association, who wrote an editorial in today's New England Journal of Medicine. And because the vaccine protects against only 70% of cervical cancers, women will still need to undergo regular cervical cancer screenings.
Haug has other questions: How will the vaccine will affect the body's natural immune system, which usually clears most HPV infections on its own? How will the vaccine affect other strains of HPV that aren't targeted by the vaccine? Will these strains become more common? Will vaccination give girls and women a false sense of protection, leading them to skip screenings that could be life-saving?
Because the vaccine is new, it's possible that other serious problem could surface later. Doctors also don't know if the vaccine's immunity will fade over time, she writes.http://www.latimes.com/features/health/la-he-gardasil11-2008aug11,0,2921629.storyGardasil vaccine doubts grow
A SHOT AT PREVENTION: Since 2006, about 8 million U.S. females reportedly have received the Gardasil vaccine.
The safety and effectiveness of the HPV vaccine Gardasil as a preventive cervical cancer treatment for girls are questioned in a report.
In addition, because Gardasil protects only against the HPV strains linked most strongly to cervical cancer, "we don't know if it will make a difference in the ultimate rates of cancer," says Abby Lippman, an epidemiologist at McGill University in Montreal who has researched the HPV vaccine. "The jury is still out on how much benefit we're actually going to get with this vaccine."
A report released in June stirred up more doubts. Although cause and effect were not proved, the report listed serious events -- such as seizures, spontaneous abortions and even deaths -- among teens, preteens and young women who had earlier had Gardasil shots. As a result, the decision -- to vaccinate or not? -- has become controversial. Sorting through the pros and cons can be daunting for many parents.
The price may not be worth it, says Dr. Karen Smith-McCune, an obstetrician and gynecologist at the UC San Francisco School of Medicine. Because it takes years for cervical cancer to develop, it is easily preventable as long as HPV infection is detected early. Though the cancer is common in developing countries and kills more than 280,000 women worldwide every year, it is much less of a health threat in the U.S., she says, where 11,000 women are diagnosed with the disease annually, and about 3,700 will die of it. The comparatively low U.S. incidence of cervical cancer is due to one of the public health system's triumphs: widespread use of Pap smears, which detect abnormal cervical cells so they can be removed before they turn into cancers. Adoption of the Pap test caused a reduction of cervical cancer rates by 74% between 1955 and 1992, according to the American Cancer Society. Rates continue to drop by 4% each year. "The crux of it is that we know how to prevent cervical cancer," Smith-McCune says. "One of the key questions is whether this huge outlay of money for the vaccine is a better strategy than reaching out to the women who aren't getting Pap tests and follow-ups."
It is not yet proven that Gardasil actually prevents cervical cancer, which can take a decade to develop after HPV infection, because tests of the vaccine before the FDA greenlighted it didn't run long enough to prove that conclusively. "Even though it guards against two HPV strains, the other HPV types need to be taken into account," Smith-McCune says. "It will take a long time before we know the true efficacy of the vaccine." ...http://www.newsweek.com/id/154381 This week's NEJM report indicates that the vaccine appeared to be cost-effective for 12-year-olds, assuming that immunity doesn't wane after 10 years; in that case, a booster shot would be required. It also found that "catch-up" programs for 20-somethings may be too expensive.
An NEJM editorial accompanying the study raises other questions about whether the vaccine provides lifelong protection from the virus and whether it should be required by public health officials. "This is still an experiment. And it should be treated that way," says Charlotte Haug, editor in chief of the Journal of the Norwegian Medical Association and author of the NEJM editorial. "There are good reasons to take a deep breath and keep doing the research." ...http://www.pharmalot.com/2008/08/merck-runs-a-gardasil-special-for-docs/Merck Runs A Gardasil Special For Docs
As Gardasil revenue disappoints, the drugmaker is scrambling for ways to boost (pun intended) sales of the controversial HPV vaccine. So Merck is now promising docs a free replacement dosage if an insurer refuses coverage, according to Maggie McGlynn, who heads Merck’s vaccines business and mentioned the effort during a conference call with institutional investors arranged by Deutsche Bank today.
Unfortunately for Merck, too many docs have been asking their patients to first check with their health insurers to see if the shots would be covered. As you can imagine, this led to fewer shots.
So McGlynn told the crowd that by having the replacement program, “they will convert to same-day vaccination.” However, this only applies to women between 19 and 26 years old, since younger women and girls can get vaccinated through government-funded programs. The stipulation also extends only to those with private health insurance. You can read the terms right here.
Given the insurance hurdles and controversy over side effects, we wonder why Merck didn’t bring back the Gardasil beach tower at the start of summer to generate some interest.http://abclocal.go.com/wabc/story?section=news/health&id=6340202Save lives, but at what cost? The shots have caused almost 10,000 adverse reactions, 94 percent of which were minor, such as headache, nausea and fever. The worst, however, include paralysis and some fatalities. There have been deaths reported soon after women had received the Gardasil vaccine, but the Centers for Disease Control and the FDA say there is no clear evidence that the deaths were caused by the vaccine.
Also, because the vaccine is so new, it's not clear how long immunity will last. "It's not uncommon among other vaccinations," said Dr. Samantha Feder, of St. Luke's/Roosevelt Hospital. "Other vaccinations will require booster shots along somebody's lifetime."
Women will still need pap tests, as there are some strains of HPV not covered by the vaccine. The shots may make women feel falsely protected, and more likely to miss their paps.http://www.gisborneherald.co.nz/Default.aspx?s=3&s1=2&id=4825Safety of cervical vaccine questioned
Friday, 22 August 2008
By Jessica Wauchop
The roll-out and safety of the new government-funded human papillomavirus (HPV) vaccine came under fire at a Tairawhiti District Health Board meeting this week. Reports of girls having anaphylactic fits and suffering nasty side-effects from the vaccine, more commonly known as Gardasil, which protects against cervical cancer, was brought to the table by board member Brian Wilson.
However, questions have been asked in Australia, where a number of Gardasil recipients say they suffered anaphylaxis, a severe reaction which can lead to a rapid pulse, profuse sweating, laboured breathing and unconsciousness. A total of 1013 suspected adverse events following injections of Gardasil were reported in Australia by June this year - the free immunisation schedule was announced in December 2006. ...
Only 12 confirmed cases of anaphylaxis were reported. The estimated rate of anaphylaxis in Australia is 3.2 per million doses. Other vaccines given to children and adolescents around the world have estimated rates that range from 0 to 3.5 per million doses.http://thestar.com.my/news/story.asp?file=/2008/8/17/focus/22087835&sec=focusWonder vaccine gets its share of complaints
Unfortunately, the excitement of discovering Gardasil as a protection against the cancer viruses has been marred by the controversy in Australia and the United States on its supposed adverse side effects.
Complaints included temporary paralysis after the vaccine injections, mouth seizure, temporary speechlessness, allergic reactions, headache and soreness.
Year 12 students from the Sacred Heart School in Melbourne were among the first to report adverse reactions after they had been injected with the vaccine.http://www.whptv.com/news/local/story.aspx?content_id=da813200-cdb5-46b8-9e4e-f774bc187aabGardasil Vaccine: Is it safe?
Reported by: Shannon Davidson
The Gardasil Vaccine protects against the Human Papillomavirus, or HPV, which can cause Cervical Cancer. For most girls, they get the three shots and they're done. But, it was a different story for a local girl. Megan Waleff, 13, was pitching at her championship softball tournament two days before leaving for a trip to Australia with 30 other kids as a student ambassador with People to People. Just a few days into her trip Megan was experiencing odd symptoms like slowed speech, and loss of motor skills. "It all of a sudden got really bad and I tripped a couple of times. That's when they took me to the doctor," says Megan.
You can see in Megan's travel journal that as the trip went on her handwriting got progressively worse. The hospital in Darwin, Australia called her parents back home. At first, doctors said she may have had a stroke. "And when they said that I just about fainted," says Megan's mom, Brenda Waleff.
After more tests, the doctors ruled out a stroke, tumors, and Lyme Disease. But there was swelling in Megan's brain. Then they asked Megan's mom if she'd had any vaccinations lately. She had. Two weeks earlier, she'd received the Gardasil Vaccine. "And so when it was her 13 year check-up, they suggested we get it done. So, I thought, 'Ok, then it'll be done,'" says Brenda.
Megan's mom says cancer runs in the family, so she was all for protecting her daughter against cervical cancer. However, she's convinced the Gardasil Vaccine is what caused Megan's symptoms.http://kaaltv.com/article/stories/S551856.shtml?cat=10219"Anytime you have an immunization, there's always a chance of an adverse reaction,” says Jay Fotland a nurse practitioner.
While the shots are working fine for many, a new article in the New England Journal of Medicine points to a list of health problems in girls and young woman who recently got the vaccines.
In two years, there are 78 reported outbreaks of genital warts, 18 deaths, and six cases of Guillaine Syndrome that can result in paralysis.
"The doctors were assuring me that it will be okay and that it wouldn't hurt or anything. Nothing happened afterwards so I was happy,” says Claire Christian, who got the vaccine last year. "I just think you weight the odds and the odds of protecting them are higher than the odds of a side effect,” says mother, Joan.http://www.lohud.com/apps/pbcs.dll/article?AID=2008808220360Two years after a controversial vaccine designed to protect women from cervical cancer became available, some local doctors remain divided on its use while a local assemblywoman is seeking to mandate it for young girls. A study in this week's New England Journal of Medicine questions the cost-effectiveness of the human papillomavirus vaccine for older girls and women. Commonly called HPV, the virus is sexually transmitted and can cause cervical cancer in some women. ...
Other local doctors, like Ephraim E. Resnik, a Pomona gynecologic oncologist, are still skeptical. He has long had concerns about the HPV vaccine. He worries that women who get the series of vaccines will assume - wrongly -that they are fully protected from cervical cancer and stop getting annual Pap tests. Resnik and Zurhellen both oppose policies that would make the vaccine mandatory.
"The worst thing we could do is institute mandatory vaccination against what is essentially a screenable and very curable cancer," Resnik said.
Resnik thinks that the idea of a vaccine to prevent cancer is still one worth pursuing. But there is too much hype about the HPV vaccine. "Our zeal for a vaccine to prevent cancer has overthrown the cool rationale that physician-scientists are supposed to have when we recommend something for an individual or a whole population," Resnik said.http://seekingalpha.com/article/92131-mercks-gardasil-a-risky-and-unnecessary-vaccineHow Merck got politicians and parents to put Gardasil up there in importance with vaccines for such deadly diseases as polio and smallpox, explains why Gardasil was named “Brand of the Year” by Pharma Executive Magazine, and won the 2008 Pharmaceutical Advertising and Marketing Excellence awards. According to The New York Times, Merck paid hundreds of doctors and nurses $4,500 for each 50 minute talk performed on Gardasil over Merck-sponsored meals. Many even got paid just to attend “advisory board” meetings on the vaccine. Despite the vaccine’s questionable effectiveness for young women in their late teens and early twenties, Gardasil has got promoted from college campuses to ads airing before “Sex and the City” at movie theaters. Merck pays Cornerstone Government Affairs to lobby Congress and the CDC for more federal money for vaccines.
Virginia will become the only state requiring girls get Gardasil to go to school, unless parents opt out. Governor Kaine signed the legislation after Merck said it would spend $57 million to expand its Elkton plant that makes the vaccine. $193 million more was pledged by Merck after the governor signed the bill, with the state providing a $1.5 million grant (on top of a $700,000 grant from an agency that is part of the executive branch). Lieutenant governor Bolling is an active participant in the “Ending Cervical Cancer in Our Lifetime” campaign of the NLGA, financed by Merck and GlaxoSmithKline (GSK), who has a competing vaccine awaiting FDA approval. Mandatory Gardasil for school girls in Texas was signed by the governor and overturned by the legislature after the governor’s former chief of staff was hired by Merck and contributed $6,000 to Governor Perry and $38,000 to other state legislators.
Gardasil retails between $400 to $1,000 for the series of three shots. Gardasil was studied in clinical trials for five years, and as The New England Journal of Medicine article states, “the overall effect of the vaccines on cervical cancer remains unknown.” There are more questions than answers available about Gardasil’s long term effectiveness. To quote a Gardasil ad: “The duration of protection has not been established.” Clinical trials were conducted on 16-24 year old women, not the 11-12 year old girls who the CDC and FDA view as the ideal target, so how it will affect them is still unknown. In some girls in the trials, the vaccine’s immunity was gone after three years. The CDC’s voluntary Vaccine Adverse Events Reporting System has logged 6,667 US reports on Gardasil from its June 8, 2006 FDA approval to June 30, 2008. Reports ranging from pain and soreness at the injection site, to nausea and fainting were most commonly reported. Cases of paralysis and 17 US deaths were reported, but the CDC/FDA could not determine if Gardasil was the cause. Gardasil is being given to many girls who are not even menstruating yet; no one knows if these girls’ future fertility/babies will be adversely affected.
The purpose of vaccines prior to Gardasil has been to protect the person receiving the shot from the disease and to protect the community from a contagion spreading. HPV doesn’t spread through airborne or casual contact, and through early detection, is treatable. Policymakers should not be wasting money on a vaccine with little to possibly even a detrimental return when there are so many serious health needs that go unmet in America. I urge parents and young women to look beyond the slick ads and do some serious research on this. When medical providers and politicians tout Gardasil, investigate their vested interest.http://www.fool.com/investing/value/2008/08/21/a-gardasil-gotcha.aspxGetting a drug through the FDA often isn't enough for drug companies. To make money, they've also got to persuade someone -- usually health insurers like UnitedHealth Group (NYSE: UNH) or Aetna (NYSE: AET) -- to pay for the product.
That's what makes this week's article and editorial in The New England Journal of Medicine about Merck's (NYSE: MRK) Gardasil so worrisome for Merck and GlaxoSmithKline (NYSE: GSK). Glaxo is hoping to bring its own human papillomavirus (HPV) vaccine, Cervarix, to the U.S. market. The article basically concludes that the vaccination is worth the money -- about $360 to $400 for a three-dose series -- for young girls, but not for women in their 20s. One of the authors said that "the vaccine becomes less cost-effective" for older women.
The problem is that Gardasil is approved for females aged 9 through 26. That's fine as far as it goes, but Merck has been trying to get it approved for women through age 45. Even if it succeeds in getting the label expanded, it might be difficult to get insurers and government agencies to pay for the vaccine.
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